Surgery Or Lifestyle Intervention for Type 2 Diabetes (SOLID)



Status:Recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:September 2009
Contact:Jacque Spitzer, M.S.
Email:jspitzer@mail.med.upenn.edu
Phone:215-746-1281

Use our guide to learn which trials are right for you!

Lifestyle Intervention Versus Bariatric Surgery for Type 2 Diabetes


This research study will investigate the safety and effectiveness of weight loss surgery for
overweight persons with type 2 diabetes. Eligible patients will undergo one of 2 types of
weight loss surgery, Roux-en-Y gastric bypass, or laparoscopic adjustable gastric banding,
or an intensive lifestyle modification. Participants will be closely followed for one year
to compare the effects of these treatments on diabetes remission.


Inclusion Criteria:

- Ages 18 to 65 years old.

- Diagnosis of type 2 diabetes.

- Individuals with a BMI of 30-40 kg/m2

- Approval for bariatric surgery (as confirmed by medical evaluation)

- Insurance coverage for bariatric surgery

- Willingness to change diet, physical activity and weight.

- Ability to communicate with the investigator and be legally competent, provide
written informed consent.

Exclusion Criteria:

- Diagnosis of type 1 diabetes, diagnosis of maturity-onset diabetes of the young
(MODY), or latent autoimmune diabetes in adults (LADA) (all of which are associated
with ß-cell destruction), daily insulin requirements > 100 units, and poor
preoperative glycemic control, as indicated by a HbA1c > 6.5 - ≤ 8.5 or HbA1c >
8.6 - < 9.5 (individuals with this HbA1c value will require medical clearance and
approval from the study physician).

- Children and adolescents are not eligible to participate in the study.

- Pregnant women (or those who intend to become pregnant during the study period) and
women who are currently breastfeeding are not eligible to participate.

- Use of medications known to significantly increase body weight, such as chronic
systemic steroids or certain psychiatric medications (e.g., lithium tricyclic
antidepressants and anti-psychotic agents).

- Non-ambulatory individuals, defined as those who are unable to walk at least one city
block without a cane or walker.

- Any major illnesses that the surgical team believes present too great a risk for
surgery. These include severe cardiac and pulmonary diseases, as well as
uncontrolled type 2 diabetes.

- Evidence of major depression or other psychiatric disorder (schizophrenia, bipolar
disorder, major depression, bulimia nervosa, etc.) that is uncontrolled, poorly
controlled, or, in the opinion of the Investigators, significantly interferes with
daily living and functioning.

- Any current (past 12 months) substance abuse or dependence disorder.

- Participants with moderate anemia (Hgb < 12 mg/dl for men and Hgb < 11 mg/dl for
women)

- Conditions that may falsely elevate or decrease HbA1c values, including hemolytic or
iron-deficiency anemia, hemoglobinopathies, and uremia.

- Abnormal laboratory tests which are clinically significant per the investigator.
We found this trial at
1
site
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials